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Sanofi/Regeneron's Cemiplimab Wins FDA Nod for Skin Cancer

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Sanofi (SNY - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved their PD-1 inhibitor cemiplimab for a type of skin cancer, which will be marketed by the trade name of Libtayo.

Cemiplimab is approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. The FDA’s decision came much earlier than the scheduled date of Oct 28. Cemiplimab is under review in the EU.

The biologics license application (BLA) for cemiplimab included positive top-line efficacy results from a pivotal phase II study EMPOWER-CSCC 1 and data from two advanced CSCC expansion cohorts from another phase I study. Combined data from these studies demonstrated an overall response rate of 47%.

This year so far, Sanofi’s shares have returned 3.9%, underperforming the 7.1% increase for the industry.



Per the company’s press release, CSCC is the second most common and deadliest skin cancer after melanoma in the United States. The disease is also responsible for the largest number of deaths among non-melanoma skin cancer patients. It accounts for an estimated 7,000 deaths annually in the United States. Although it is easier to treat the condition in early stages, it’s quite difficult to treat once it has progressed to advanced stages. Hence, the candidate is expected to provide the company with access to a market promising huge potential.

Libtayo will be sold in the United States at a list price, or wholesale acquisition cost, of $9,100 per three-week treatment cycle.

Cemiplimab isalsobeing studied as monotherapy as well as in combination with other therapies in a wide range of cancers including non-small cell lung cancer, advanced basal cell carcinoma, cervical cancer and lymphomas.

Other PD-1/PD-L1 inhibitors on the market are Merck’s (MRK - Free Report) Keytruda, Bristol Myers’ Opdivo, Roche’s Tecentriq and AstraZeneca’s (AZN - Free Report) Imfinzi. Libtayo marks the entry of Sanofi and Regeneron in this space

The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1 has risen significantly in the past couple of years. It is estimated that their market will rise tremendously in the next four to five years. PD-1 and PD-L1 are proteins present on the surface of immune cells

Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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